The disclosure relates to the use of inhaled CV therapies in combination with electronic monitoring devices.
Cardiac arrhythmia (also dysrhythmia) is a term for any of a large and heterogeneous group of conditions in which there can be abnormal electrical activity in the heart. The heart beat may be too fast or too slow, and may be regular or irregular.
Cardiac Arrhythmia is a field with a high level of unmet clinical need. Many drugs used today have been on the market since the early 1980s and 1990s and are mostly inadequate due to either lack of efficacy or a side-effect profile that can be primarily cardiac related, that necessitates extensive monitoring of the subject.
Atrial Fibrillation is a type of Cardiac arrhythmia that occurs as both symptomatic and asymptomatic. When symptomatic the subject goes to the ER in the hospital for treatment while when asymptomatic that subject does not realize that they are in an arrhythmic state. Atrial fibrillation normally occurs asymptomatically before it becomes symptomatic in short durations. These short episodes spontaneously convert into normal sinus rhythm. But the cumulative effect of these short episodes add to the overall AF burden and eventual progression of the disease.
Paroxysmal atrial fibrillation (PAF) is a subset of the overall Atrial Fibrillation (AF) population and is estimated to be a third of the overall AF population. AF affects about 34 million people worldwide and 11.3 million of these people worldwide are diagnosed as subjects with PAF.
Arrhythmias frequently result in emergency room (ER) visits, where intravenous drugs are administered, and sometimes necessitating extended stay in hospital and in some cases also leading to unplanned invasive procedures.
Ablation can be expensive and can be about 50% efficacious. Despite the high expense, ablation may not completely correct the arrhythmia. Often, multiple ablation procedures are required to achieve a satisfactory result in a subject's lifetime. Ablation also results in heart related medical complications associated with morbidity and mortality.
Electronic Monitoring systems are used in subjects to monitor if they are experiencing such arrhythmias and when an arrhythmia is sustained they are recorded and the treating physician is able to assess the course of therapy.
What is needed for slowing the progression of AF from its starting paroxysmal state to permanent AF.
None of the current oral or IV approved drug products are combined with an electronic monitoring system with the goal to terminate the arrhythmia at initiation thereby reducing the progression of the disease, the overall AF burden leading to significant reduction in the economies of hospital costs.
Exemplary monitoring devices include the AliveCor Mobile ECG, the Reveal LINQ Insertable Cardiac Monitor, the iRhythm ZIO XT Patch, the HeartCheck pen, the AfibAlert, smartphone or portable music player applications designed to detect arrhythmias, the Microlife AFIB Technology device, the WatchBP device, Holter monitors, Smart watches, wearable technology such as those that can vibrate as a means to detect an arrhythmia, or any other similar devices.